Cleared Traditional

PARAMED PARAFFIN WARMER

K991427 · Divi Intl. Co. · Physical Medicine

Aug 1999

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K991427 is an FDA 510(k) clearance for the PARAMED PARAFFIN WARMER, a Bath, Paraffin (Class II — Special Controls, product code IMC), submitted by Divi Intl. Co. (Miami, US). The FDA issued a Cleared decision on August 13, 1999, 112 days after receiving the submission on April 23, 1999. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5110.

Submission Details

510(k) Number	K991427 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 1999
Decision Date	August 13, 1999
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement